Cleared Traditional

K143192 - Vanguard 360 Revision Knee System

K143192 is an FDA 510(k) clearance for Vanguard 360 Revision Knee System, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K143192 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
98d
Days
Class 2
Risk

K143192 is an FDA 510(k) clearance for the Vanguard 360 Revision Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 12, 2015 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet, Inc. devices

FDA 510(k) Submission Details - K143192

510(k) Number K143192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2014
Decision Date February 12, 2015
Days to Decision 98 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 887
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K143192.
Consensus Knee System Modular Tibial Baseplate
K143725 · Consensus Orthopedics, Inc. · Mar 2015
KINETIS Total Knee System
K143635 · Mako Surgical · Feb 2015
Klassic Knee System-Sombrero Patella
K150105 · Total Joint Orthopedics, Inc. · Feb 2015
Visionaire Disposable Instruments
K143226 · Smith & Nephew, Inc. · Feb 2015
Biomet Tibial trays
K142933 · Biomet, Inc. · Dec 2014
Zimmer Persona Personalized Knee System
K142787 · Zimmer, Inc. · Dec 2014